IDE or IND Transfers

The investigator who holds an Investigational Device Exemption (IDE) may transfer the IDE to a new owner. This may be necessary when the Sponsor-Investigator is leaving the university or no longer has the resources to fulfill Sponsor -Investigator responsibilities.

To transfer the IDE, both the new and former owners are required to submit information to the FDA. This includes a letter from the former owner identifying the new sponsor, effective date and stating that all rights to the application have been transferred to the new owner and that the new owner will receive or has received the complete IDE record. The new owner also needs to submit a letter agreeing to accept the IDE along with the new owner's agreement to comply with any terms or outstanding conditions of approval of the investigation. Additional specific forms required are listed in the checklist below.

To help you with the transfer process, please click the links below:

• IDE Transfer Checklist (DOCX)
• IDE Transfer Request Template New S-I (DOCX)
• IDE Transfer Request Template Transferring S-I (DOCX)

The investigator who holds an IND may transfer the IND to a new owner. This may be necessary when the Sponsor-Investigator is leaving the university or no longer has the resources to fulfill Sponsor -Investigator responsibilities.

In order to transfer the IND, both the new and former owners are required to submit information to the FDA. This includes a letter from the former owner stating that all rights to the application have been transferred to the new owner and that the new owner will receive or has received the complete IND record. The new owner also needs to submit a letter agreeing to accept the IND & along with the new owner's commitment to agreements, promises, and conditions made by the former owner and contained in the application. Additional specific forms required are listed in the checklist below.

To help you with the transfer process, please click the links below:

• IND Transfer Checklist (DOCX)
• IND Transfer Request Template New S-I (DOCX)
• IND Transfer Request Template Transferring S-I (DOCX)